Ethics

U.S. attempting to flout ethical practice for patient trials abroad

Published in Lab Law Weekly, April 22nd, 2005

The U.S. Food and Drug Administration (FDA) has proposed that observing a widely accepted code of medical ethics that protects patients who take part in trials is not necessary for studies conducted abroad.

The 2000 Declaration of Helsinki, produced by 82 national medical associations, states that, "At the conclusion of the study, every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic and therapeutic methods identified in the study" and places some limits on the use of placebos in studies conducted in developing countries.

Current FDA regulations require studies submitted in support of a new drug...

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Source: Lab Law Weekly (2005-04-22)

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